A Setback for Generic Consumers

May 21, 2015

The road to recovery for generic drug consumers just got more difficult. After a series of rulings from the U.S. Supreme Court over the past few years, a person injured from a generic drug is almost entirely unable to bring a lawsuit against the manufacturer of that generic drug. Why? Because the generic drug and its warning label must, by federal regulation, be the same as the brand-name. A handful of states, however, have given hope to the generic consumers by allowing lawsuits to be brought against the brand-name manufacturer directly in these instances. Alabama stood at the forefront, when its Supreme Court became the highest state court to allow such claims in Wyeth vs. Weeks, 2014 Ala. LEXIS 109 (Ala. Aug. 15, 2014).Alabama State Capitol

Taking a significant step backwards in this movement, the governor of Alabama signed into law SB80, which expressly states that a manufacturer cannot be held liable under any theory for damages related to a product which it did not manufacture or sell, even if the product in question is the same or equivalent to its own. This law effectively overturns Weeks and directly prohibits claims against a brand-name manufacturer of a drug for injuries resulting from the generic version.

Though only one state, prior to its new law Alabama had demonstrated movement in the right direction for generic consumers, and provided a feasible cause of action through which generic consumers could pursue legal action. Unfortunately, Alabama’s law now follows the trend of most states—where statutes directly prohibit such lawsuits or courts have excluded such claims.

As this Alabama saga illustrates, the status of where and how legal claims can be brought in cases involving generic drugs is ever changing. We continue to await a final rule from the FDA which will allow generic manufacturers to update warning labels on their own, placing responsibility back on the generic manufacturers and exposing them to liability for their failure to warn of the risks and dangers associated with their drugs. The question of who is responsible for updating product warnings, and how it should be done, continues to be evaluated by the FDA. Only time will tell how this will ultimately be decided; a decision that will surely have a great impact on consumers.


Photo Credit: Jim Bowen


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